FDA approves Telix's Pixclara, first FET-PET imaging drug for glioma in the U.S.

The U.S. Food and Drug Administration has granted approval to Telix Pharmaceuticals' Pixclara, a fluorine‑18 labeled amino acid PET tracer designed for imaging gliomas. This marks the first FDA‑cleared FET‑PET imaging agent for brain tumors.

Pixclara (floretyrosine F‑18) can be used with PET scans to help differentiate recurrent or progressive glioma from treatment‑related changes in both adults and children older than one month. Gliomas account for roughly 80% of malignant brain tumors, with about 24,000 new cases each year in the United States.

The approval follows an earlier rejection in April, when the FDA requested additional confirmatory clinical evidence. Telix’s CEO highlighted that the cleared drug will give clinicians greater diagnostic certainty and confidence in treatment planning for patients with glioma.